Kornimate/medical-research-clean huggingface dataset:
raltegravir switch for toxicity or adverse events

Conditions: HIV/AIDS; Antiretroviral Therapy; HIV Infections

Summary: this study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.


Eligibility criteria:
inclusion criteria: * patients treated with a combined antiretroviral therapy from at least 1 year * aged 18 years or older * with one or more of the following conditions: * grade 3 or 4 dyslipidemia * any hyperglycemia * lipodystrophy (patient's self report, confirmed by physician's physical examination) * moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%) * diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week) * with at least two hiv-rna levels \<50 copies/ml on two consecutive determinations at least 3 months apart * with cd4 cell count \>200 cells/ μl for at least 6 months and absence of any opportunistic infection or aids-related disease during the last year before screening. * who gave informed consent to the participation to the study exclusion criteria: * pregnancy or breast feeding, desire of pregnancy in the short term * previous virological failure (two consecutive hiv-rna levels \> 50 copies/ml or a single value \>1000 copies/ml) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs. * previous exposure to inhibitors of hiv-1 integrase * previous major toxicity to any of the study drugs * spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years * current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient's adherence to the new drug regimen and/or to the protocol's procedures * patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)

Keywords: raltegravir switch toxicity treatment experienced
an integrative approach for idiopathic granulomatous mastitis.

Conditions: Idiopathic Granulomatous Mastitis

Summary: collaboration is established between turkish holistic \& integrative medicine association and traditional \& complementary medicine society of istanbul medipol university. study is carried out on idiopathic granulomatous mastitis patients who are followed in the breast clinic at istanbul medipol university hospital for between september 2015 and september 2019. hirudotherapy and medical cupping therapy were applied as traditional and complementary medicine integratively. following initial radiological imaging, microbiological- and histological testing, side effects and relapses are analyzed. follow-up examination is also carried out at the end of the treatment, which consisted of clinical breast exam and radiological imaging.


Eligibility criteria:
inclusion criteria: * igm patients, either ones newly diagnosed or had previously received different types of treatments, currently refusing conventional treatments with immunosuppressives etc, or/and surgical management, and now und exclusion criteria: * patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.

Keywords: integrative medicine ethnomedicine hirudotherapy idiopathic granulomatous mastitis medical cupping therapy traditional and complementary medicine
a study to investigate the bioequivalence test of da-1229_01(a) at fed state

Conditions: Type2 Diabetes

Summary: a study demonstrates the bioequivalence of da-1229_01(a) at fed state when compared with sugamet sustained-release(sr) tab 5/1000mg® in healthy adults


Eligibility criteria:
inclusion criteria: * adult patients over 19 years of age at the time of health examination * female patients who were confirmed to be not pregnant at health examination * patients without a history of mental illness in the past 5 years exclusion criteria: * patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial * patients with a congestive heart failure which requires medicinal treatment * patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial * female patients who are lactating
open-label safety extension study assessing safety and tolerability of lai in patients who participated in study ins-212

Conditions: NTM Lung Infection Due to MAC

Summary: this is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg liposomal amikacin for inhalation (lai) added to a multi-drug regimen in participants with nontuberculous mycobacterial (ntm) lung infections due to mycobacterium avium complex (mac) who were refractory to therapy and failed to convert in study ins-212 (nct02344004).

safety and tolerability of once daily dosing of 590 mg liposomal amikacin for inhalation (lai) added to a multi-drug regimen in participants with non-tuberculous mycobacterium (ntm) lung infections due to mycobacterium avium complex (mac) who are refractory to therapy and failed to convert in study ins-212. participants participating in study ins-212 who had not achieved the ins-212 protocol definition of culture conversion (3 consecutive monthly negative sputum cultures) or who had experienced a relapse or recurrence (agar positive or more than 2 consecutive broth positive results after culture conversion had occurred) by month 6, as determined by their sputum culture results from day 1 through month 6 and confirmed at their scheduled month 8 visit, were eligible to participate in study ins-312. for participants who chose to participate in study ins-312, the month 8 visit of study ins-212 became their end of treatment (eot) visit; these participants were then asked to provide written informed consent for study ins-312 and were enrolled directly into study ins-312 after having met all eligibility criteria. participants in study ins-212 had either received 590 mg lai plus an mdr (lai + mdr arm) or a multidrug regimen alone (mdr alone arm). all participants in this safety extension study were to continue the multidrug antimycobacterial regimen that they were receiving during study ins-212 and will receive lai 590 mg administered daily (qd) for up to 12 months. the participants will remain in the study for up to a total of 13 months (up to 12 months on-treatment plus 1 month off lai treatment for safety follow up).

Eligibility criteria:
key inclusion criteria: 1. had successfully completed the month 6 and end of treatment visits in study ins-212 2. had not achieved the ins-212 protocol definition of culture conversion by month 6 in study ins-212 or had experienced a relapse or recurrence by month 6 in study ins-212. key exclusion criteria: 1. achieved culture conversion without relapse or recurrence in the study ins-212 study by month 6

Keywords: alis arikayce
efficacy of interval aerobic training versus laser puncture therapy on restless leg syndrome in copd patient

Conditions: Chronic Obstructive Pulmonary Disease

Summary: determine how to improve the quality of life for patients with copd by decreasing tintensity of the restless syndrome

patients with restless legs syndrome can benefit greatly from aerobic exercise, and a novel treatment for enhancing quality of life is laser puncture therapy.

Eligibility criteria:
inclusion criteria: * men with copd who were between the ages of 40 and 60 and had a bmi between 25.5 and 29.0 were eligible to enroll if they had received a diagnosis of copd at least two years prioran intense desire to move the legs is frequently accompanied by unpleasant and uncomfortable leg sensations. patients usually experience worsening symptoms when they are at rest, sitting, or lying down. walking and stretching are examples of physical activity that can help reduce these symptoms to some or all of their intensity exclusion criteria: * 1) individuals suffering from acute infections and malignant diseases; 2) individuals with a history of kidney disease, hiatus hernia, severe gastro-esophageal reflux, and osteoporosis 3) patients with severe anemia and congestive heart failure 4) individuals with severe neurological and musculoskeletal conditions.

Keywords: restless leg syndrom,lazer puncture therapy
intelligent cardiopulmonary rehabilitation system for patients with chronic stroke

Conditions: Stroke

Summary: by comparing with traditional aerobic exercise training (taet), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (icrs) on cardiopulmonary fitness and patient satification among patients with chronic stroke.

cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. however, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity. to address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. the purpose of the current study is to investigate the feasibility of the icrs in stroke patients and whether it outweighs the traditional feedback on training intensity. a single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group a and group b. group a received training with icrs while group b received training with taet at the beginning. the intensity of icrs is set as 60%\~80% heart rate reserve (hrr) which is obtained from cardiopulmonary exercise testing (cpet) at pretest. the intensity of taet is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. subjects are crossed-over to the alternate treatment afterwards. cpet evaluations will be conducted in a total of 4 times before and after treatment.

Eligibility criteria:
inclusion criteria: * aged 20-75 y/o * healthy people * chronic stroke \> 6 months * able to walk independently \> 6 minutes with or without orthosis * able to use stationary bike * mrs(modified rankin scale) ranged 1 to 3 exclusion criteria: * patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users) * with any reason that the patient is not suitable to undergo aerobic training * patients who are unable to do cycling due to musculoskeletal problems * patients who can not follow the instruction of trainers due to cognitive or emotional-problems. * patients whose medical condition is not unstable.

Keywords: cardiopulmonary exercise cardiorespiratory fitness aerobic training
periodized rehabilitation and beta-alanine supplementation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: exercise therapy and increased physical activity in persons with multiple sclerosis (ms) improves mobility, muscular strength, physical fitness and fatigue without increasing relapse rate. as such, physical activity and more particular exercise therapy have become an important part of ms rehabilitation. despite the fact that the positive effects of exercise therapy in ms are obvious only 43 percent of the ms community reports to participate in an exercise program4. therefore, new exercise therapy approaches that further optimize rehabilitation, improve exercise adherence and promote participation in physical exercise in ms are interesting to explore. therefore, the randomized controlled trial investigates two types of exercise interventions (classic progressive vs periodized) with or without the addition of ergogenic supplements (beta-alanine vs placebo).

following inclusion, baseline measurements (pre) will be performed in ms patients (n=80). first, static(isometric) muscle strength (dynamometry), exercise capacity (maximal graded exercise test) and body composition (dexa) will be evaluated. after 4 days of recovery, m. vastus lateralis muscle samples (bergström procedure) will be taken. hereafter, ms patients will be randomly allocated to one of four intervention groups following either 12 weeks of 'classical' moderate intensity cardiovascular exercise therapy (n=40) or periodized exercise therapy (n=40), with (msβclassic, n=20; msβperiod, n=20) or without (msclassic, n=20; msperiod, n=20) β-alanine supplementation. groups not receiving β-alanine supplements, will receive placebo tablets that will be identical in taste and appearance. to evaluate post training fatigue, perceived exertion will be recorded following each training session (6-20 borg scale). following 12 weeks of classic or periodized training post intervention measurements will be performed similar to baseline.

Eligibility criteria:
inclusion criteria: * diagnosis multiple sclerosis. * healthy control. * aged \>18y. * written informed consent. exclusion criteria: * contraindications to perform moderate to high intensity exercise. * participation in another study. * experienced acute ms related exacerbation \<6 months prior to start of the study * edss score \> 6

Keywords: rehabilitation periodized exercise therapy ergogenic supplementation
nursing care with patients with venous leg ulcers

Conditions: - Venous Leg Ulcers

Summary: aims are: * develop an internet-based education programme about venous leg ulcer nursing care (elc) * evaluate the clinical, cognitive and economical outcomes of education programme research questions are: 1. what are the cognitive outcomes of elc (perceived knowledge, attitudes towards venous leg ulcer nursing care, theoretical knowledge level and practical knowledge)? hypotheses for research question 1 are: 1. nurses using the elc will have better knowledge (perceived, practical and theoretical knowledge) than those who will not use the elc. 2. nurses using the elc will have more positive attitudes towards venous leg ulcer nursing care than those who will not use the elc. 2. what are the clinical outcomes of elc (ulcer healing, ulcer size, treatment supplies)? hypotheses for research question 2 are: 1. ulcer healing progresses better among patients who are taken care by nurses using the elc. 2. ulcer sizes will be 10 % smaller among the patients cared for nurses using the elc. 3. nurses using the elc will use mire adequate treatment supplies than those who will not use the elc. 3. what are the economical outcomes (treatment time and supply usage) of elc? hypothesis for research question 3 is: 1. the economical expenditures will be lower among nurses using the elc. the ultimate aim is to promote evidence-based nursing care among patients with venous leg ulcer.

the study takes place in home-care in two finnish municipality, which are similar size and staff structure and working ideology are basically the same. enrolment of participants has started with information occasion in both municipalities in june 2014. nurses were asked to fill the patients clinical situation questionnaire, handouts and forms for informed consent were delivered. (figure 1) all eligible nurses and patients will be identified with patient clinical assessment. the sample size was determined with power analysis and the result was that 200 nurses are needed in the intervention group and 100 nurses in the comparison group.

Eligibility criteria:
inclusion criteria for nurses: 1. working in municipality home-care 2. permanent attachment or three months or longer temporary post in municipality home-care 3. working in home-care area where patients with chronic leg ulcer are taken care during the study exclusion criteria for nurses: 1. working in other place than home-care there are no other exclusion criteria. inclusion criteria for patients to observation are: 1. home health-care patient aged 60 or over 2. venous leg ulcer diagnosis 3. chronic ulcer in the lower leg without diagnosis exclusion criteria for patients: 1. an ulcer with other diagnosis than venous leg ulcer diagnosis there are no other exclusion criteria for patients.
to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of inhaled azd8683

Conditions: Healthy

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing single doses of azd8683 administered via inhalation

a phase i, single centre, double-blind, randomised, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled azd8683 after single ascending doses administered via turbuhaler in healthy subjects

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures healthy male subjects aged 18 * 45 years with suitable veins for cannulation or repeated venepuncture * male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product * have a body mass index (bmi) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive exclusion criteria: * history or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product * abnormal vital signs, after 10 minutes supine rest, defined as any of the following: * systolic blood pressure \>140 mm hg * diastolic blood pressure \>90 mm hg * heart rate \ 85 beats per minute any clinically important abnormalities in rhythm, conduction or morphology of resting ecg. this includes subjects with any of the following: * pr(pq) interval prolongation \>200 ms or dropped beats (single non conducted p-waves) based on screening or prolonged qtcf \>450 ms or shortened qtcf \<340 ms or family history of long qt syndrome

Keywords: phase 1 healthy volunteers safety tolerability pharmacokinetics single ascending dose study
eular impact of rheumatic and musculoskeletal diseases survey

Conditions: Rheumatologic Disease; Musculoskeletal Diseases

Summary: the eular impact of rmds survey collects first-hand information about the impact of rheumatic and musculoskeletal diseases (rmds) among patients across and beyond europe. through periodic questionnaires, patients will provide information about their healthcare situation, and how the disease affects their social and occupational lives. this data will be an important resource for researchers, healthcare professionals, and patients alike, providing valuable insights into the burden of disease and helping improve the overall care for people living with these conditions.


Eligibility criteria:
inclusion criteria: * 18-year-old at time of baseline survey * living in a eular country at time of baseline survey * diagnosed with at least one rmd * valid personal e-mail address * being able to use an internet website exclusion criteria: * none
brachytherapy radiation directly to the liver in breast cancer patients with metastatic to liver

Conditions: Breast Cancer Metastatic to the Liver

Summary: the purpose of this study to study whether or not the use of direct radiation therapy with y-90 microspheres (sir-spheres) has any effect on treated liver with respect to tumor response in breast cancer patients. criteria: * breast cancer * clinical evidence of metastatic disease in the liver * performance status (0-2) * not pregnant * laboratory values received after any prior chemotherapy * normal pt/ptt * recovered from any chemotherapy side-effects * no prior radiation therapy to the liver * no other major site of cancer such as lungs or brain * no uncontrolled infections * a candidate for surgical resection or ablation therapy

patient must pass an maa angiography study to detect abnormal shunting of the vessels to the lungs and stomach. shunting of the radiation seeds to these areas, if an abnormality exists would be harmful.

Eligibility criteria:
inclusion criteria: * documented breast cancer * clinical evidence of mets to the liver * performance status of 0-2 * life expectancy of greater equal to 3 months * not pregnant * 4 weeks or more since last radiation therapy * recovered from all side effects of prior chemotherapy * not needing concurrent chemotherapy * recovered laboratory values * bilirubin \< 2.0 exclusion criteria: * candidate for surgical resection or ablation of liver lesion/s * prior radiation therapy to the liver * co-morbid disease * pulmonary insufficiency * portal vein thrombosis * contraindications to angiography * \> 20 % lung shunting on maa * diffuse extra-hepatic disease * concurrent chemotherapy or capecitabine with 8 weeks * failed maa * uncontrolled active infection * severe liver dysfunction

Keywords: cancer breast liver